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Product specialists.  What we're striving to do here is develop highly trained FDA product specialists to basically help in strengthening consistency in regulatory decisions and ensure submission reviews and that the inspections are coordinated and synergistic.  Again, we will have people in the centers, in the field, who have the technical information that's really necessary to get into the more complicated areas of manufacturing and understand those as we do inspections and reviews.

Team biologics.  In the Center for Biologics Evaluation and Research, they do their cGMPs a little bit differently.  They have an internal team.  The team biologics has been in existence for awhile, and looking at that, how team biologics works and the effectiveness of it has been studied for awhile, and now it's been built into this drug product quality systems initiative.  And basically we're looking at improving the operations of team biologics and building on the implementation of a quality management system.  And as the CDER/CBER consolidation becomes effective, obviously some things with team biologics are going to change a little bit to align them with how CDER does business.  So there are some

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